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Cisplatin and Etoposide With or Without Veliparib in Treating Patients With Extensive Stage Small Cell Lung Cancer
Phase 1, PHASE2 trial testing Cisplatin in Extensive Stage Small Cell Lung Carcinoma in 156 participants. Completed in 2 July 2018.
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 156 |
| Start date | 28 September 2012 |
| Primary completion | 8 December 2016 |
| Estimated completion | 2 July 2018 |
| Sites | 428 locations across United States |
National Cancer Institute (NCI)
18 and older, any sex, with Extensive Stage Small Cell Lung Carcinoma or Large Cell Lung Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
dose of veliparib which was deemed to be the recommended phase II dose to be administered in the combination with CE for the phase II clinical trial
| Group | Value | 95% CI |
|---|---|---|
| Phase I | 100 |
Profession free survival (PFS) is defined as time from randomization to date of disease progression or death from any cause, whichever occurred first. Patients who had not experienced an event of interest by the time of analysis were censored at the date they were last known to be alive and progression-free. Tumor response was evaluated via Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria, and progression was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study, or appearance of one or more new lesions
| Group | Value | 95% CI |
|---|---|---|
| Phase II: Arm D (Veliparib) | 6.1 | 5.9 – 6.2 |
| Phase II: Arm E (Placebo) | 5.5 | 5.1 – 5.7 |
| Group | Value | 95% CI |
|---|---|---|
| Phase II: Arm D (Veliparib) | 6.2 | 5.9 – 7.5 |
| Phase II: Arm E (Placebo) | 5.1 | 4.3 – 5.5 |
| Group | Value | 95% CI |
|---|---|---|
| Phase II: Arm D (Veliparib) | 6.0 | 5.8 – 6.3 |
| Phase II: Arm E (Placebo) | 5.6 | 5.3 – 6.3 |
Overall survival (OS) is defined as time from randomization to death from any cause. Median OS was estimated using the Kaplan-Meier method.
| Group | Value | 95% CI |
|---|---|---|
| Phase II: Arm D (Veliparib) | 10.3 | 8.9 – 12.0 |
| Phase II: Arm E (Placebo) | 8.9 | 8.3 – 11.3 |
Tumor response was evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. Complete response (CR) was defined as disappearance of all target lesions. Partial response (PR) was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Overall response rate= (CR+PR)/all eligible and treated patients
| Group | Value | 95% CI |
|---|---|---|
| Phase II: Arm D (Veliparib) | 72 | 59 – 82 |
| Phase II: Arm E (Placebo) | 66 | 53 – 77 |
Neurotoxicity total score was measured by the 11 items in the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaire. Each item was scored from 0-4. The severity of neurotoxicity was measured by the total score of the 11 items, ranged from 0 to 44. Lower values of the FACT/GOG-Ntx neurotoxicity total score indicate higher neurotoxicity.
| Group | Value | 95% CI |
|---|---|---|
| Phase II: Arm D (Veliparib) | -0.1 | ± 4.8 |
| Phase II: Arm E (Placebo) | -1.8 | ± 6.4 |
Time frame: Assessed every cycle (1 cycle= 21 days) while on treatment and for 30 days after the end of treatment. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Phase I: Arm A (Dose Level… | Phase I: Arm B (Dose Level… | Phase II: Arm D (Veliparib) | Phase II: Arm E (Placebo) |
|---|---|---|---|---|---|
| Neutrophil count decreased | Investigations | — | — | — | — |
| Anemia | Blood and lymphatic system disorders | — | — | — | — |
| White blood cell decreased | Investigations | — | — | — | — |
| CD4 lymphocytes decreased | Investigations | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — | — |
| Platelet count decreased | Investigations | — | — | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — | — | — |
| Acute kidney injury | Renal and urinary disorders | — | — | — | — |
| Hypertension | Vascular disorders | — | — | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — | — | — |
| Atrial flutter | Cardiac disorders | — | — | — | — |
| Heart failure | Cardiac disorders | — | — | — | — |
| Death NOS | General disorders | — | — | — | — |
| Fever | General disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Duodenal infection | Infections and infestations | — | — | — | — |
| Lymphocyte count decreased | Investigations | — | — | — | — |
| Weight loss | Investigations | — | — | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — | — | — |
| Dizziness | Nervous system disorders | — | — | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Reaction | System | Phase I: Arm A (Dose Level… | Phase I: Arm B (Dose Level… | Phase II: Arm D (Veliparib) | Phase II: Arm E (Placebo) |
|---|---|---|---|---|---|
| Alopecia | Skin and subcutaneous tissue disorders | — | — | — | — |
| Anemia | Blood and lymphatic system disorders | — | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — | — |
| Fatigue | General disorders | — | — | — | — |
| Platelet count decreased | Investigations | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Neutrophil count decreased | Investigations | — | — | — | — |
| White blood cell decreased | Investigations | — | — | — | — |
| Dysgeusia | Nervous system disorders | — | — | — | — |
| Tinnitus | Ear and labyrinth disorders | — | — | — | — |
| Chills | General disorders | — | — | — | — |
| Fever | General disorders | — | — | — | — |
| Infusion related reaction | General disorders | — | — | — | — |
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | — | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — | — |
| Mucositis oral | Gastrointestinal disorders | — | — | — | — |
| Lymphocyte count decreased | Investigations | — | — | — | — |
| Investigations - Other, specify | Investigations | — | — | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — | — | — |
| Metabolism and nutrition disorders - Other, specify | Metabolism and nutrition disorders | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Peripheral sensory neuropathy | Nervous system disorders | — | — | — | — |
| Depression | Psychiatric disorders | — | — | — | — |
| Sore throat | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Flushing | Vascular disorders | — | — | — | — |
Most-reported serious reactions: Neutrophil count decreased, Anemia, White blood cell decreased, CD4 lymphocytes decreased, Nausea, Dehydration, Fatigue, Diarrhea.
Data from ClinicalTrials.gov NCT01642251 adverse events section.
This randomized phase I/II trial studies the side effects and best dose of veliparib when given together with or without cisplatin and etoposide and to see how well they work in treating patients with extensive stage small cell lung cancer or large cell neuroendocrine non-small cell lung cancer that has spread to other parts of the body. Drugs used in chemotherapy, such as cisplatin and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving cisplatin and etoposide with or without veliparib may work better in treating patients with extensive stage small cell lung cancer or metastatic large cell neuroendocrine non-small cell lung cancer.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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